Workshop on Clinical Research and Medical Regulation Sep 27, 2016
IISER Pune along with CDSA, Prashanti Cancer Care Mission and NCL Venture Centre is organising a 3-day workshop on:
Clinical Research and Medical Regulation
(September 27-29, 2016)
The workshop will have three sessions:
Current Regulation & Guidelines in India for Clinical Trials
Current Ethical & Regulatory Requirements for Clinical Trial/Research
Current Regulations on Medical Devices & in vitro Diagnostic Kits
Individuals can register for any one or two or all three days. Cick here for registrations.
Current Regulation & Guidelines in India for Clinical Trials
Venue: Sir CV Raman Auditorium, Lecture Hall Complex, IISER Pune
Date: September 27, 2016
One Day Awareness Program on Good Clinical Practice. This program will give participants an overview about various aspects starting from the differences in the guidelines from CDSCO, ICH to WHO, various regulatory requirements, ethical considerations, roles and responsibilities of various stakeholders like Sponsor, Institution, Investigator, Monitor etc. It will make participants aware of various clinical trial documentation requirements like protocol, investigator’s brochure, informed consent form, case record form, clinical study report etc. This will make the participants understand and learn record keeping and data handling requirements and quality assurance in the conduct of a clinical trial or research, when done in compliance with GCP requirements.
Learning Objective:
To understand the basics of Good Clinical Practice, so that the participants can imbibe them and ensure compliance, give public an assurance that the rights, safety and well-being of human subjects involved in research are well protected.
Expected Outcome:
At the end of the program, the participants should be:
- Aware about the basic concepts of GCP
- Understand Indian Regulations that govern human research
- Know how to ensure protection of rights, safety and welfare of human participants
- Be cognizant of quality, reliability and integrity of data.
- Know the ‘Do’s and ‘Don’ts' and be able to identify ‘right’ from ‘wrong’ approaches
- Get acquainted with various standards and guidelines for the conduct of clinical research
- Understand the simple formula, Good Clinical practice = Ethics + Quality Data
Target Participants:
Investigators, Ethics Committee Members, Clinical trial or research team members. Any one working in the area of clinical trial or research or aspires to work in this area.
Current Ethical & Regulatory Requirements for Clinical Trial/Research
Venue: Sir CV Raman Auditorium, Lecture Hall Complex, IISER Pune
Date: September 28, 2016
Learning Objective:
To strengthen and empower the Institutional Ethics Committee (IEC) members to ensure that they understand scientific, regulatory norms, ethical design, conduct and reporting of clinical research that will be of uniform nature and meets national and international quality standards.
Expected Outcome:
At the end of the program, the participants will be aware about current guidelines and regulations for the conduct of clinical research in India so as to ensure that the right, safety and well-being of human participants involved in research are well protected.
Target Participants:
Members from Ethics Committees will be given priority. Investigators and clinical trial/research team members are encouraged to apply.
Current Regulations on Medical Devices & in vitro Diagnostic Kits
Venue: NCL Venture Centre, Pune
Date: September 29, 2016
Learning Objective:
To provide direct, relevant and valuable information on key aspects of Medical Devices & in vitro Diagnostic Kits including its regulations in India.
Expected Outcome:
At the end of the program, the participants will be aware about the regulations that govern medical devices and in vitro diagnostic kits in India and will be cognizant about design and development of medical devices, various standards, CE Certifications & ISO 13485. They will understand biocompatibility and clinical trial of medical device and know regulations for import, manufacture and sale of medical devices. It will provide an opportunity to the participants to meet the regulators and clarify doubts.
Target Participants:
SMEs, Academic Research Organisation, Investigators involved in Medical Devices & Diagnostics.
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